# US 2019/0167590 A1 · Micronized Opioid Compositions, Formulations and Dosage Forms and Methods of Making Same

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- Number: US 2019/0167590 A1
- Document ID: US20190167590A1
- Status: Published application
- Kind: A1
- Application number: 16/142,639
- Filed: 2018-09-26
- Published: 2019-06-06
- Earliest claimed: 2007-12-06
- Inventors: Michael Zamloot; Cherng-Chyi Fu; De-Hwa Chao; Andrei Blasko; Su Il Yum
- Web page: https://patentgrep.com/patent/US20190167590A1

## CPC

- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Novel compositions, formulations and dosage forms comprising stabilized micronized opioid particles are disclosed. Exemplary opioids include oxycodone, oxymorphone, hydrocodone, and hydromorphone, including as free bases or as salts. Stabilized micronized opioid particles having a DV90 particle size distribution of less and or equal to 10μ or less than or equal to 20μ are disclosed. Methods for micronizing an opioid to provide stabilized micronized opioid particles are also disclosed.

## Claims

### Claim at position 1

1-39. (canceled)

### Claim 40

A composition comprising stabilized micronized oxycodone particles, wherein the oxycodone particles have a DV90 particle size distribution of less than or equal to 10 μm.

### Claim 41 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles are in the form of a salt.

### Claim 42 (depends on 41)

The composition of claim 41, wherein the stabilized micronized oxycodone particles are stabilized micronized oxycodone HCl particles.

### Claim 43 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles are stabilized micronized oxycodone freebase particles.

### Claim 44 (depends on 40)

The composition of claim 40, wherein ≤1% of the stabilized micronized oxycodone particles have a particle size ≤0.2 μm.

### Claim 45 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 30 ppm of α,β-unsaturated ketones (ABUK).

### Claim 46 (depends on 40)

The composition of claim 40, wherein the composition comprises 5 mg of the stabilized micronized oxycodone particles.

### Claim 47 (depends on 40)

The composition of claim 40, wherein the composition comprises 10 mg of the stabilized micronized oxycodone particles.

### Claim 48 (depends on 40)

The composition of claim 40, wherein the composition comprises 20 mg of the stabilized micronized oxycodone particles.

### Claim 49 (depends on 40)

The composition of claim 40, wherein the composition comprises 30 mg of the stabilized micronized oxycodone particles.

### Claim 50 (depends on 40)

The composition of claim 40, wherein the composition comprises 40 mg of the stabilized micronized oxycodone particles.

### Claim 51 (depends on 40)

The composition of claim 40, wherein the composition is a non-aerosol composition.

### Claim 52 (depends on 40)

The composition of claim 40, wherein the composition is provided in a liquid suspension or a non-tablet dosage form.

### Claim 53 (depends on 40)

The composition of claim 40, wherein the composition is suitable for oral administration.

### Claim 54 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 25 ppm of ABUK.

### Claim 55 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 20 ppm of ABUK.

### Claim 56 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 15 ppm of ABUK.

### Claim 57 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 10 ppm of ABUK.

### Claim 58 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 5 ppm of ABUK.

### Claim 59 (depends on 40)

The composition of claim 40, wherein the stabilized micronized oxycodone particles comprise less than or equal to 1 ppm of ABUK.